Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Notices 3145 

FOR FURTHER INFORMATION CONTACT: 

Laurie Muldowney, Center for Drug 

Evaluation and Research (HFD–003), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 51, rm. 

4154, Silver Spring, MD 20993–0002, 

301–796–1571. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Size of Beads in Drug Products Labeled 

for Sprinkle.’’ This draft guidance 

provides sponsors of NDAs, ANDAs, 

and BLAs CDER’s current thinking on 

appropriate size ranges for beads in drug 

products that are labeled to be 

administered via sprinkling (e.g., 

capsules or packets containing beads). 

Certain drug products that contain 

beads within a capsule indicate on the 

labeling that the capsule can be broken 

and the internal beads can be sprinkled 

on soft foods and swallowed without 

chewing as an alternative 

administration technique. This is 

particularly common with drug 

products designed to have extended- or 

delayed-release characteristics (i.e., the 

beads are manufactured to release the 

drug product at different rates). To make 

certain that the intended product 

performance is achieved—be it from a 

capsule that has been broken or from a 

packet containing beads—it is important 

to have reasonable assurance that the 

patient will be able to swallow the 

beads with the food that the beads are 

mixed with without stimulating the urge 

to chew. Additional assurances may be 

needed when the label also includes 

language for alternate administration via 

an enteral feeding tube. 

The recommendations in this draft 

guidance are based on literature on 

chewing and swallowed particle size 

and on Agency experience with NDAs 

and ANDAs submitted for these dosage 

forms. Three parameters are considered 

in this draft guidance as they relate to 

drug products labeled for sprinkle: (1) 

Appropriate maximum size for the 

beads, (2) special considerations for 

sprinkle drug products that include 

language for alternate administration via 

an enteral feeding tube, and (3) how to 

address potential bead size differences 

between reference listed drugs and 

ANDAs and meet bioavailability (BA) or 

bioequivalence (BE) recommendations. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on size of beads in drug products 

labeled for sprinkle. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). Information 

submitted in an NDA, ANDA, or BLA 

supporting the appropriate size for 

beads in drug products that are labeled 

to be administered via sprinkling, 

including related BA and BE studies, is 

approved by OMB under control 

number 0910–0001 for NDAs and 

ANDAs and control number 0910–0338 

for BLAs. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: January 12, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–1001 Filed 1–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0611] 

Pediatric Device Consortia Grant 

Program (P50) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of the Office of Orphan 

Products Development (OOPD) Pediatric 

Device Consortia Grant Program. The 

goal of the Pediatric Device Consortia 

Grant Program is to promote pediatric 

device development by providing grants 

to nonprofit consortia whose business 

model and approach to device 

development will either result in, or 

substantially contribute to, market 

approval of medical devices designed 

specifically for use in children. The 

program does not support the 

development of single device projects. 

Although administered by the Office of 

Orphan Products Development, this 

grant program is intended to encompass 

devices that could be used in all 

pediatric conditions or diseases, not just 

rare diseases. The pediatric population 

(neonates, infants, children, and 

adolescents) includes patients who are 

21 years of age or younger at the time 

of diagnosis or treatment. 

DATES: Important dates are as follows: 

1. The application due date is May 2, 

2011. 

2. The anticipated start date is 

September, 2011. 

3. The opening date is January 15, 

2011. 

4. The expiration date is May 3, 2011. 

For Further Information and 

Additional Requirements Contact: 

Linda C. Ulrich or Debra Y. Lewis, 

Office of Orphan Products 

Development, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg 32, rm. 5271, Silver Spring, 

MD 20993–0002, 301–796–8660 or 

Camille Peake, Office of Acquisitions & 

Grant Services, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

2139, Rockville, MD 20852, 301–827– 

7175. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA when posted and 

located at: http://grants.nih.gov/grants/ 

guide/index.html. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

RFA–FD–011–002. 

Catalog of Federal Domestic 

Assistance Number: 93.103. 

A. Background 

The development of pediatric medical 

devices currently lags 5 to 10 years 

behind the development of devices for 

adults. Children differ from adults in 

terms of their size, growth, 

development, and body chemistry, 

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3146 Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Notices 

adding to the challenges of pediatric 

device development. There currently 

exists a great need for medical devices 

designed specifically with children in 

mind. Such needs include the original 

development of pediatric medical 

devices, as well as the specific 

adaptation of existing adult devices for 

children. Thus, as part of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA), Congress passed the 

Pediatric Medical Device Safety and 

Improvement Act of 2007. Section 305 

of FDAAA requires the Secretary of 

Health and Human Services to provide 

demonstration grants or contracts to 

nonprofit consortia to promote pediatric 

device development. 

B. Research Objectives 

The goal of FDA’s Pediatric Device 

Consortia Grant Program is to promote 

pediatric device development by 

providing grants to nonprofit consortia. 

The consortia will facilitate the 

development, production, and 

distribution of pediatric medical devices 

by: (1) Encouraging innovation and 

connecting qualified individuals with 

pediatric device ideas with potential 

manufacturers; (2) mentoring and 

managing pediatric device projects 

through the development process, 

including product identification, 

prototype design, device development, 

and marketing; (3) connecting 

innovators and physicians to existing 

Federal and non-Federal resources; (4) 

assessing the scientific and medical 

merit of proposed pediatric device 

projects; and (5) providing assistance 

and advice as needed on business 

development, personnel training, 

prototype development, post-marketing 

needs, and other activities. 

C. Eligibility Information 

The grants are available to any 

domestic, public or private, nonprofit 

entity (including State and local units of 

government). Federal agencies that are 

not part of the Department of Health and 

Human Services (HHS) may apply. 

Agencies that are part of HHS may not 

apply. Organizations that engage in 

lobbying activities, as described in 

section 501(c)(4) of the Internal Revenue 

Code of 1968, are not eligible to receive 

grant awards. 

II. Award Information/Funds Available 

A. Award Amount 

Approximately $2.5 million will fund 

two to four new awards. Grants will be 

awarded up to $1,500,000 in total cost 

(direct costs plus indirect costs) per 

year. 

B. Length of Support 

Grants will be awarded on a 

competitive basis for up to 2 years. 

III. Paper Application, Registration, 

and Submission Information 

To submit a paper application in 

response to this FOA, applicants should 

first review the full announcement 

when posted and located at http:// 

grants.nih.gov/grants/guide/index.html. 

(The FDA has verified the Web site 

addresses throughout this document, 

but FDA is not responsible for any 

subsequent changes to the Web sites 

after this document publishes in the 

Federal Register). Persons interested in 

applying for a grant may obtain an 

application at http://grants.nih.gov/ 

grants/funding/phs398/phs398.html. 

For all paper application submissions, 

the following steps are required: 

• Step 1: Obtain a Dun and Bradstreet 

(DUNS) Number. 

• Step 2: Register With Central 

Contractor Registration. 

Steps 1 and 2, in detail, can be found 

at http://www07.grants.gov/applicants/ 

organization_registration.jsp. After you 

have followed these steps, submit paper 

applications to: Division of Acquisition 

Support and Grants, Office of 

Acquisition & Grant Services, 5630 

Fishers Lane, rm. 2128, Rockville, MD 

20857, 301–827–7175. 

Dated: January 13, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–997 Filed 1–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; The 

Atherosclerosis Risk in Communities 

Study (ARIC) 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request for review and approval the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on October 12, 2010, page 

62544, and allowed 60 days for public 

comment. No comments were received. 

The purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: The 

Atherosclerosis Risk in Communities 

Study (ARIC). Type of Information 

Collection Request: Revision of a 

currently approved collection (OMB 

NO. 0925–0281). Need and Use of 

Information Collection: ARIC will 

conduct a clinical examination of the 

cohort over a 24-month period (May 

2011 to April 2013). In addition, this 

project involves biennual follow-up by 

telephone of participants in the ARIC 

study, review of their medical records, 

and interviews with doctors and family 

to identify disease occurrence. 

Interviewers will contact doctors and 

hospitals to ascertain participants’ 

cardiovascular events. Information 

gathered will be used to further describe 

the risk factors, occurrence rates, and 

consequences of cardiovascular disease 

in middle aged and older men and 

women. Frequency of Response: The 

participants will be contacted biannually for follow-up. A subset of the 

cohort may choose to volunteer for the 

clinical examination; these individually 

will be contacted once in a 3 year 

period. Affected Public: Individuals or 

households; Businesses or other for 

profit; Small businesses or 

organizations. Type of Respondents: 

Individuals or households; doctors and 

staff of hospitals and nursing homes. 

The annual reporting burden is as 

follows: Estimated Number of 

Respondents: 12,673; Estimated Number 

of Responses per Respondent: 2.7; 

Average Burden Hours per Response: 

0.5916; and Estimated Total Annual 

Burden Hours Requested: 20,434. The 

annualized cost to respondents is 

estimated at $355,882, assuming 

respondent’s time at the rate of $17.00 

per hour and physician time at the rate 

of $75.00 per hour. There are no Capital 

Costs to report. There are no Operating 

or Maintenance Costs to report. 

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